Mini Supporting Statement A

Mini Supporting Statement A For

“A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI’s Communication and Education Resources (NCI)”

(OMB No. 0925-0046-06), Expiration Date 5/31/2016)

Title of Sub-Project: Customer Feedback of the National Cancer Institute’s Mouse Models of Human Cancers Consortium (NCI-MMHCC) Program

Contact Person: Cheryl Marks

Section A.

A1. Circumstances Making the Collection of Information Necessary

Section 410 of the Public Health Service Act (42 USC § 285) authorizes the collection of the information. In 2014, The National Cancer Institute’s Mouse Models of Human Cancers Consortium (NCI-MMHCC) program, under the Division of Cancer Biology, will end. With the program ending there will no longer be a central focus for the mouse modeling program. DCB wants to explore establishing a new program that would evolve and maintain an open Oncology Models Forum that addresses mouse model issues for all cancer research communities. The in-depth interviews would provide information that informs how the NCI formulates a new program and delivers services, resources, educational products, and opportunities for cross-community collaborations (connecting mouse oncology modeling experts with members of other oncology communities).

This fits under the scope of NCI’s Generic Submission for Formative Research, Pretesting and Customer Satisfaction to “determine the level of customer satisfaction with products that help NCI identify strategies for improving the accessibility of materials/programs, their user-friendliness, and their relevance to the needs of …health care professionals…. Systematic formative research and pretesting has been widely adopted by health education program planners as an integral step in the development and targeted dissemination of messages and materials” (0925-0046, Supporting Statement A, Section A.2, p. 5). Specifically, the in-depth interviews would contribute to the Human Cancer Consortium program’s communication strategy by, “understand the characteristics of the target audience…, determined the best promotion and distribution channels…, and expend limited program resource dollar wisely and effectively” (0925-0046, Supporting Statement A, Section A.2, p. 6).

A2. Purpose and Use of the Information Collection

The information will inform how the NCI formulates a new program that delivers services, resources, educational products, and opportunities for cross-community collaborations that are workable solutions for the practical needs of the entire cancer research community for appropriate, dependable mouse models.

Specifically, the in-depth interviews (Attachment 1) will collect information about:

• Who in which research community is and is not using mouse models, and why;

• The common or distinctive uses for each research community;

• Whether the interviewees are familiar with the NCI-MMHCC project and scope;

• Whether the interviewees are satisfied with the quality of the program; and,

• How the NCI-MMHCC could improve and broaden information about standard practices and SOPs to benefit oncology research communities.

A3. Use of Information Technology and Burden Reduction

In-depth interviews will be conducted with customers over the telephone. This is the most efficient and effective method to collect information that is open-ended and will allow for prompts, should clarification to responses be needed.

A4. Efforts to Identify Duplication and Use of Similar Information

Though the NIH supports mouse model initiatives, such as the Knock-Out Mouse Production and Phenotyping Consortium (part of the 18-country International Mouse Phenotyping Consortium), none of these initiatives addresses the unique needs of the cancer research community. At the present time, there is no other organized oncology research community forum that enables experts in generating and using animal models to link with those in other cancer research or translational communities for mutual benefit.

A5. Impact on Small Businesses or Other Small Entities

No small businesses will be interviewed for this project.

A6. Consequences of Collecting the Information Less Frequently

This is a one-time collection of information.

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This information collection will be implemented in a manner that fully complies with the Guidelines of 5 CFR 1320.5.

A8. Comments in Response to Federal Register Notice and Efforts to Consult Outside Agency

The Division of Cancer Biology has convened many joint workshops and meetings with members of other NCI and NIH consortia and networks to encourage animal modelers and members of other research communities to explore common problems and opportunities. The interactions at meetings have sparked new directed research collaborations that have been supported through administrative supplements or new multi-PI RO1s. However, many animal models needs of broad benefit for the cancer research community that are identified at these meetings are resources, technology, or information projects that have been unexplored and unfunded.

A9. Explanation of Any Payment or Gift to Respondents

No payments or gifts will be given to respondents.

A10. Assurance of Confidentiality Provided to Respondents

No personally identifiable information is being collected.

A11. Justification for Sensitive Questions

There are no sensitive questions being asked.

A12. Estimates of Hour Burden Including Annualized Hourly Costs

With 500 respondents being interviewed, the total estimated burden will be 292 hours.

Table A12-1. Estimates of Hour Burden

Category of Respondent	Instrument	No. of Respondents	Participation Time (in hours)	Total Burden Hours
Individuals	Consent	500	5/60	42
	Interview Guide	500	30/60	250
Total				292

The mean hourly wage rate for scientists according to the May 2012 National Occupational Employment and Wage Estimates in the United States (http://www.bls.gov/oes/current/oes_nat.htm) is $32.87. With a total burden of 292 hours, this amounts to

Table A12-2. Cost to Respondents:

Category of Respondent	Number of Respondents	Total Burden Hours	Wage Rate	Respondent Cost
Individuals	500	292	$32.87	$9,598.04

A13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no capital costs, operating costs, or maintenance costs to report.

A14. Annualized Cost to the Federal Government

The annualized and total cost to the Federal Government of this assessment is estimated to cost $30,000 (Table A.14-1). The costs are primarily associated with the contractor. The cost of the Federal employee is $4,713 and for the contractors $25,287.

Table A14-1 Annualized Cost to the Federal Government

Staffing	Task	Annualized Cost
NCI	Program Director, Grade 15, Step 10 (3% time for 12 months)	$4,713
Contractor	Project Management Support which includes scheduling interviews, collecting data, data analysis, and final report to NCI	$25,287
Total		$30,000

A15. Explanation for Program Changes or Adjustments

This is a new, generic sub-project.

A16. Plans for Tabulation and Publication and Project Time Schedule

Simple descriptive statistics will be employed for some of the questions. For the other questions, qualitative techniques will be used to analyze and identify common themes.

The interviews will begin once OMB approval is granted. Interviews will occur over a four month period of time, then analysis and summaries will be conducted. The contractor will provide NCI will a summary report of findings.

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate

The OMB Clearance Number, Expiration Date, and Burden Disclosure Statements will be displayed on the applications.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the Certification for Paperwork Reduction Act Submissions.

List of Attachments

Attachment #1: Interview Guide

Attachment #2: Invitation Email

Attachment #3: Consent Form

Short Title: MouseModels 1 5/7/2014